Clinical Research Manager
1 week ago
Clinical Trial and RWE Study Management
We are seeking an experienced Clinical Research Manager to oversee the design, planning, and execution of clinical trials and Real-World Evidence (RWE) studies. The ideal candidate will have a strong understanding of clinical trial regulations, including ICH-GCP, FDA, and EMA guidelines.
Scientific Writing and Documentation
The selected candidate will be responsible for authoring and reviewing scientific reports, clinical study reports, abstracts, and peer-reviewed manuscripts. They will also contribute to the preparation of documents for regulatory submissions, including protocols, informed consent forms, and Investigator's Brochures.
Regulatory and Ethical Compliance
The successful candidate will ensure that all studies comply with current legal and ethical guidelines. They will prepare and submit regulatory documents to ethics committees and institutional review boards (IRBs). Additionally, they will maintain proper documentation and ensure that all study-related materials are archived according to regulatory and company standards.
Data Management and Reporting
The Clinical Research Manager will be responsible for overseeing data collection, quality control, and statistical analysis. They will also ensure accurate and timely reporting of clinical trial and RWE study outcomes. The selected candidate will present findings at internal meetings, external conferences, and publish in scientific journals.
Team Leadership and Collaboration
The ideal candidate will lead and mentor clinical research coordinators, associates, and scientific writing staff. They will collaborate with external clinical investigators, study sites, and other vendors to ensure seamless study execution. The selected candidate will work closely with cross-functional teams, including medical, regulatory, data management, and data science teams to drive study success.
Risk Management and Problem Solving
The Clinical Research Manager will identify and mitigate risks during clinical trials and RWE studies to prevent delays or non-compliance. They will proactively address operational and technical issues related to trial execution.
Stakeholder Communication
The selected candidate will serve as the primary point of contact for study sites, investigators, external partners, and regulatory bodies. They will provide clear and concise updates on study progress to senior management, regulatory authorities, and other stakeholders. The Clinical Research Manager will collaborate with key opinion leaders (KOLs), medical affairs teams, and data scientists to align research with strategic objectives.
Other Tasks
The successful candidate will carry out additional tasks and responsibilities as assigned by the reporting manager, contributing to the overall success of the clinical research team and project objectives.
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